Withings Hypertension Notification Retrospective Study

Validation of the Withings Hypertension Notification Feature (HTNF)

This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic, anthropometric, and physiological parameters collected by Withings connected smart scales to identify patterns suggestive of hypertension. Ground-truth blood pressure measurements are obtained concurrently from Withings connected blood pressure monitors.

Hypertension affects approximately 1.4 billion adults worldwide and is the leading modifiable risk factor for cardiovascular disease. The Withings Hypertension Notification Feature (HTNF) is a software-only medical device (Software as a Medical Device, SaMD) that analyzes demographic, anthropometric, and physiological parameter data opportunistically collected by Withings connected smart scales to identify patterns suggestive of hypertension and provide a notification to the user. Ground-truth hypertension status is defined at the user-week level as a weekly average systolic blood pressure (SBP) >= 130 mmHg or diastolic blood pressure (DBP) >= 80 mmHg (2017 ACC/AHA guideline), based on a minimum of 7 weekly blood pressure measurements from Withings BPM devices.

Data were collected retrospectively between 2019 and 2026 from consumer users of commercially available Withings smart scales who received an information letter and did not opt out. No prospective measurements or interventions are performed.

Inclusion Criteria:

• Users of commercially purchased, consumer-grade Withings smart scales (models Body Cardio, Body Comp, Body Scan) in a standard home environment
• Concurrent ground-truth blood pressure data collected via Withings connected blood pressure monitors (BPM, BPM+, BPM Connect, or BPM Core)
• At least 7 blood pressure measurements within a given week to establish reliable weekly hypertension status classification
• Age >= 18 years (all regions) or >= 22 years (United States), consistent with the predicate device age requirement
• Receipt of the study information letter without exercising the right to opt out (for applicable regulatory jurisdictions)

Exclusion Criteria:

• Users lacking valid weekly average systolic and diastolic blood pressure measurements (missing ground truth)
• Users with physiological measurements falling outside plausible clinical ranges (BMI < 10 or > 100 kg/m2, age < 18/22 or > 100 years)
• Users who exercised their right to opt out of the retrospective study
• Users without an individual Withings account (shared accounts are excluded to prevent data contamination)